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Lcr35 for Children With Functional Constipation

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ClinicalTrials.gov Identifier: NCT01985867
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Katarzyna Wojtyniak, Medical University of Warsaw

Brief Summary:
The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Lactobacillus casei rhamnosus Lcr35 Dietary Supplement: Placebo Phase 4

Detailed Description:
Functional constipation is a common problem which affects over 3% of children. The standard treatment does not provide sustained relief of symptoms. As a consequence, there is interest in other therapeutic options. Previously, one small (n=40) randomized controlled trial (RCT) involving 27 children showed that Lactobacillus rhamnosus casei Lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. However, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. Available evidence is insufficient to draw meaningful conclusion. Further studies are needed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Lactobacillus Casei Rhamnosus Lcr35 in the Management of Children With Functional Constipation: a Randomized, Double-blind, Placebo- Controlled Trial.
Study Start Date : November 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Lactobacillus casei rhamnosus Lcr35
Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10^8 colony forming units (CFU), twice daily, orally for 4 weeks
Dietary Supplement: Lactobacillus casei rhamnosus Lcr35
Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)

Placebo Comparator: Placebo
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
Dietary Supplement: Placebo
Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks




Primary Outcome Measures :
  1. treatment success (≥3 spontaneous defecations per week with no fecal soiling) [ Time Frame: in the fourth week of the intervention ]

Secondary Outcome Measures :
  1. stool consistency (with the use of the Bristol Stool Scale Form) [ Time Frame: during 4 weeks of intervention ]
  2. stool frequency [ Time Frame: during 4 weeks of intervention ]
  3. fecal soiling episodes [ Time Frame: during 4 weeks of intervention ]
  4. pain during defecation [ Time Frame: during 4 weeks of intervention ]
  5. abdominal pain and/or flatulence [ Time Frame: during 4 weeks of intervention ]
  6. use of laxatives [ Time Frame: during 4 weeks of intervention ]
  7. adverse effects [ Time Frame: during 4 weeks of intervention ]
  8. fecal microbiological sampling (global evolution of Lactobacillus and Bifidobacterium) [ Time Frame: during 4 weeks of intervention ]
    fecal sampling will be performed before and at the 4th week of intervention



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children below 5 years of age
  • Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:

    • Two or fewer defecations per week
    • At least 1 episode per week of incontinence after the acquisition of toileting skills
    • History of excessive stool retention
    • History of painful or hard bowel movements
    • Presence of a large fecal mass in the rectum
    • History of large- diameter stools that may obstruct the toilet

Exclusion Criteria:

  • Irritable bowel syndrome
  • Mental retardation
  • Endocrine disease (e.g. hypothyroidism)
  • Organic cause of constipation (e.g. Hirschsprung disease)
  • Spinal anomalies
  • Anatomic defects of the anorectum
  • History of previous gastrointestinal surgery
  • Functional nonretentive fecal incontinence
  • Use of drugs that influence gastrointestinal motility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985867


Locations
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Poland
Department of Pediatrics, Medical University of Warsaw
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Hania Szajewska, MD Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katarzyna Wojtyniak, MD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01985867     History of Changes
Other Study ID Numbers: 1-2013
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms